Notice2022-11277
Gilead Sciences, Inc.; Withdrawal of Approval of Indications for Relapsed Follicular Lymphoma and Relapsed Small Lymphocytic Lymphoma for ZYDELIG (Idelalisib) Tablets
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Published
May 26, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for relapsed follicular lymphoma and relapsed small lymphocytic lymphoma for ZYDELIG (idelalisib) Tablets, approved under new drug application (NDA) 205858, held by Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404 (Gilead). Gilead voluntarily requested that the Agency withdraw approval of these indications and waived its opportunity for a hearing.
Full Text
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<title>Federal Register, Volume 87 Issue 102 (Thursday, May 26, 2022)</title>
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[Federal Register Volume 87, Number 102 (Thursday, May 26, 2022)]
[Notices]
[Page 32031]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11277]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0850]
Gilead Sciences, Inc.; Withdrawal of Approval of Indications for
Relapsed Follicular Lymphoma and Relapsed Small Lymphocytic Lymphoma
for ZYDELIG (Idelalisib) Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it is withdrawing approval of the indications for relapsed
follicular lymphoma and relapsed small lymphocytic lymphoma for ZYDELIG
(idelalisib) Tablets, approved under new drug application (NDA) 205858,
held by Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404
(Gilead). Gilead voluntarily requested that the Agency withdraw
approval of these indications and waived its opportunity for a hearing.
DATES: Approval is withdrawn as of May 26, 2022.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#642f0d09060116081d4a28010c1602010800240200054a0c0c174a030b12"><span class="__cf_email__" data-cfemail="95defcf8f7f0e7f9ecbbd9f0fde7f3f0f9f1d5f3f1f4bbfdfde6bbf2fae3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On July 23, 2014, FDA approved NDA 205858
for ZYDELIG (idelalisib) Tablets for the treatment of patients with
relapsed follicular B-cell non-Hodgkin lymphoma in patients who have
received at least two prior systemic therapies (the follicular lymphoma
indication). On that same day, FDA also approved NDA 205858 for ZYDELIG
(idelalisib) Tablets for the treatment of patients with relapsed small
lymphocytic lymphoma in patients who have received at least two prior
systemic therapies (the SLL indication). FDA approved both the
follicular lymphoma indication and the SLL indication under the
Agency's accelerated approval regulations, 21 CFR part 314, subpart H.
As a condition of accelerated approval of ZYDELIG (idelalisib) Tablets
for the follicular lymphoma indication and the SLL indication, the
applicant was required to conduct postmarketing trials to verify the
clinical benefit of idelalisib for the follicular lymphoma and SLL
indications.
On November 22, 2021, FDA met with Gilead to discuss the status of
ZYDELIG (idelalisib) Tablet's accelerated approval for the follicular
lymphoma indication and the SLL indication, including the continued
need for postmarketing trials intended to verify clinical benefit in
follicular lymphoma and small lymphocytic lymphoma. FDA raised
withdrawal of approval during this discussion, explaining its intent to
consult the Oncologic Drugs Advisory Committee (ODAC) on whether FDA
should pursue withdrawal of the follicular lymphoma indication and the
SLL indication. Subsequently, on December 17, 2021, following further
communication with Gilead, FDA advised Gilead that voluntary withdrawal
of approval for these indications would be appropriate under Sec.
314.150(d) (21 CFR 314.150(d)). On January 10, 2022, Gilead submitted a
letter requesting withdrawal of the follicular lymphoma indication and
the SLL indication for ZYDELIG (idelalisib) Tablets and waiving its
opportunity for a hearing. Gilead subsequently clarified, on February
23, 2022, that they were requesting the Agency withdraw approval of the
follicular lymphoma indication and the SLL indication pursuant to Sec.
314.150(d).
Therefore, under Sec. 314.150(d), approvals of the follicular
lymphoma indication and the SLL indication for ZYDELIG (idelalisib)
Tablets are withdrawn as of May 26, 2022. Withdrawal of approval of
these indications does not affect any other approved indication for
ZYDELIG (idelalisib) Tablets.
Dated: May 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11277 Filed 5-25-22; 8:45 am]
BILLING CODE 4164-01-P
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